SHAPE-MEMORY POLYMER FOAM DEVICE FOR TREATING ANEURYSMS

• US 20140277057A1
• Filed: 03/13/2013
• Published: 09/18/2014
• Est. Priority Date: 03/13/2013
• Status: Active Grant

• Current Assignee: Lawrence Livermore National Security LLC (Government of the United States of America), Shape Memory Medical Inc., Texas A&M University System
• Original Assignee: Lawrence Livermore National Security LLC (Government of the United States of America), Jonathan Hartman, Texas A&M University System
• Inventors: Ortega, Jason M., Benett, William J., Small, Ward, Wilson, Thomas S., Maitland, Duncan J., Hartman, Jonathan
• Granted Patent: US 9,662,119 B2
• Time in Patent Office: Days
• US Class Current: 606/191
• CPC Class Codes: A61B 17/12022 Occluding by internal devices, e.g. balloons or releasable wires plugging an opening in the wall of an organ A61B17/0057; occluders for the cervical canal A61F6/146; vas deferens occluders A61F6/20
• CPC Class Codes: A61B 17/12031 complete occlusion
• CPC Class Codes: A61B 17/12113 within an aneurysm
• CPC Class Codes: A61B 17/12181 formed by fluidized, gelatinous or cellular remodelable materials, e.g. embolic liquids, foams or extracellular matrices
• CPC Class Codes: A61B 2017/0061 Implements located only on one side of the opening
• CPC Class Codes: A61B 2017/00871 polymeric
• CPC Class Codes: A61B 2017/12077 Joint changing shape upon application of heat, e.g. bi-metal or reversible thermal memory

Abstract

A system for treating an aneurysm in a blood vessel or vein, wherein the aneurysm has a dome, an interior, and a neck. The system includes a shape memory polymer foam in the interior of the aneurysm between the dome and the neck. The shape memory polymer foam has pores that include a first multiplicity of pores having a first pore size and a second multiplicity of pores having a second pore size. The second pore size is larger than said first pore size. The first multiplicity of pores are located in the neck of the aneurysm. The second multiplicity of pores are located in the dome of the aneurysm.

Claims

1. An apparatus for treating an aneurysm in a blood vessel or vein, wherein the aneurysm has a dome, an interior, and a neck;

comprising;

a shape memory polymer foam in the interior of the aneurysm between the dome and the neck,

wherein said shape memory polymer foam has pores that include

a first multiplicity of pores having a first pore size and

a second multiplicity of pores having a second pore size,

wherein said second pore size is larger than said first pore size.

2. The apparatus for treating an aneurysm of claim 1 wherein said first multiplicity of pores having a first pore size are located in the neck of the aneurysm.

3. The apparatus for treating an aneurysm of claim 1 wherein said second multiplicity of pores having a second pore size are located in the dome of the aneurysm.

4. The apparatus for treating an aneurysm of claim 1 further comprising additional multiplicities of pores in said shape memory polymer foam, wherein said additional multiplicities of pores have pore sizes larger than said first pore size but smaller than said second pore size.

5. The apparatus for treating an aneurysm of claim 4 wherein said first multiplicity of pores, said additional multiplicities of pores, and said second multiplicity of pores are located in the interior of the aneurysm with a gradation of pore size wherein the pores with the smallest pore size are in the neck of the aneurysm and the pores with the largest pore size are in the dome of the aneurysm.

6. The apparatus for treating an aneurysm of claim 1 wherein said shape memory polymer foam comprises separate pieces of shape memory polymer foam with differing pore sizes in the interior of the aneurysm between the dome and the neck.

7. The apparatus for treating an aneurysm of claim 1 wherein said shape memory polymer foam comprises a shape memory polymer foam unit with differing pore sizes in the interior of the aneurysm between the dome and the neck, said shape memory polymer foam unit having a base located in the neck of the aneurysm, and further comprising a coating of non-porous shape memory polymer on said base of the foam unit.

8. The apparatus for treating an aneurysm of claim 1 further comprising an array of non-porous baffles in said shape memory polymer foam in the interior of the aneurysm between the dome and the neck.

9. The apparatus for treating an aneurysm of claim 1 further comprising a wire backbone, wherein said shape memory polymer foam comprises a series of shape memory polymer foam pieces that are distributed along said wire backbone.

10. The apparatus for treating an aneurysm of claim 1 and further comprising a wire backbone, wherein said shape memory polymer foam comprises a single monolithic shape memory polymer foam unit located on said wire backbone.

11. The apparatus for treating an aneurysm of claim 1 wherein the aneurysm is a fusiform aneurysm having an interior and wherein said shape memory polymer foam is located in said interior of the fusiform aneurysm.

12. The apparatus for treating an aneurysm of claim 1 further comprising a void in the interior of the aneurysm, wherein said void is located in the dome of the aneurysm.

13. The apparatus for treating an aneurysm of claim 1 wherein said shape memory polymer foam comprises a shape memory polymer foam unit with differing pore sizes in the interior of the aneurysm between the dome and the neck, said shape memory polymer foam unit having a base located in the neck of the aneurysm, further comprising a coating of non-porous shape memory polymer on said base of the foam unit and further comprising a void in the interior of the aneurysm, wherein said void is located in the dome of the aneurysm.

14. A method of treating an aneurysm in a blood vessel or vein, wherein the aneurysm has a dome, an interior, and a neck;

comprising the steps of;

providing a shape memory polymer foam that has pores that include a first multiplicity of pores having a first pore size and a second multiplicity of pores having a second pore size, wherein said second pore size is larger than said first pore size; and

positioning said shape memory polymer foam in the interior of the aneurysm between the dome and the neck of the aneurysm.

15. The method of treating an aneurysm of claim 14 wherein said step of positioning said shape memory polymer foam in the interior of the aneurysm between the dome and the neck of the aneurysm comprises positioning said first multiplicity of pores having a first pore size in the neck of the aneurysm.

16. The method of treating an aneurysm of claim 14 wherein said step of positioning said shape memory polymer foam in the interior of the aneurysm between the dome and the neck of the aneurysm comprises positioning said second multiplicity of pores having a second pore size in the dome of the aneurysm.

17. The method of treating an aneurysm of claim 14 further comprising providing additional multiplicities of pores in said shape memory polymer foam, wherein said additional multiplicities of pores have pore sizes larger than said first pore size but smaller than said second pore size;

and wherein said step of positioning said shape memory polymer foam in the interior of the aneurysm between the dome and the neck of the aneurysm comprises positioning said additional multiplicities of pores have pore sizes larger than said first pore size but smaller than said second pore size in the interior of the between the neck of the aneurysm and the dome of the aneurysm.

18. The method of treating an aneurysm of claim 14 wherein said step of providing a shape memory polymer foam includes providing a shape memory polymer foam having a base, and further comprising the step of coating said base with a non-porous shape memory polymer.

19. The method of treating an aneurysm of claim 14 further comprising the step of positioning an array of non-porous baffles in said shape memory polymer foam.

20. The method of treating an aneurysm of claim 14 further comprising the steps of providing a wire backbone, and wherein said step of providing a shape memory polymer foam comprises providing a series of shape memory polymer foam pieces that are distributed along said wire backbone.

21. The method of treating an aneurysm of claim 14 further comprising the steps of providing a wire backbone, and wherein said step of providing a shape memory polymer foam comprises providing a single monolithic shape memory polymer foam unit on said wire backbone.

22. The method of treating an aneurysm of claim 14 wherein the aneurysm is a fusiform aneurysm having an interior and wherein said step of positioning said shape memory polymer foam in the interior of the aneurysm comprises positioning said shape memory polymer foam in said interior of said fusiform aneurysm.

23. The method of treating an aneurysm of claim 14 wherein said step of positioning said shape memory polymer foam in the interior of the aneurysm between the dome and the neck of the aneurysm comprises positioning said shape memory polymer foam in the interior of the aneurysm leaving a void between said shape memory polymer foam and the dome of the aneurysm.

24. The method of treating an aneurysm of claim 14 wherein said step of positioning said shape memory polymer foam in the interior of the aneurysm between the dome and the neck of the aneurysm comprises positioning said shape memory polymer foam in the interior of the aneurysm leaving a void between said shape memory polymer foam and the dome of the aneurysm;

and wherein said step of providing a shape memory polymer foam includes providing a shape memory polymer foam having a base, and further comprising the step of coating said base with a non-porous shape memory polymer.